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Recorlev Levoketoconazole 150 mg Tablet, 50-count — NDC 72065-003-01 (Billing 72065-0003-01)

by Xeris Pharmaceuticals, Inc. · 50 TABLET in 1 BOTTLE

This is a package of 50 tablets of Recorlev Levoketoconazole 150 mg Tablet from Xeris Pharmaceuticals, Inc., marketed since Dec 2021 and currently FDA-listed. It is this product's only package size.

NDC 72065-0003-01
🏷️ FDA NDC (as labeled) 72065-003-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 72065-003-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
72065 labeler · 003 product · 01 package
Package marketed since
Dec 30, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
50 EA per package
Barcode (UPC)
0372065003013
Medicaid fills, this package
316 prescriptions in the last four reported quarters
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72065-003-01
Product NDC 72065-003
11-digit billing NDC 72065000301
NCPDP billing unit EA — each (per item)
RxCUI 2588848, 2588854
UNII 2DJ8R0NT7K
UPC 0372065003013
Application # NDA214133
SPL Set ID d4c5fead-bc4a-fb02-e053-2a95a90ae4fc
Established class (EPC) Cortisol Synthesis Inhibitor
Mechanism of action Cytochrome P450 11B1 Inhibitors; Cytochrome P450 11A1 Inhibitors; Cytochrome P450 17A1 Inhibitors; Cytochrome P450 3A4 Inhibitors; P-Glycoprotein Inhibitors; Organic Cation Transporter 2 Inhibitors; Multidrug and Toxin Extrusion Transporter 1 Inhibitors; Cytochrome P450 2B6 Inhibitors; Cytochrome P450 2C8 Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-12-30
Route ORAL
Dosage form TABLET
Substance LEVOKETOCONAZOLE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 30022040000320
GCN Seq No 082947
GCN 51757
HICL code 047743
Ingredient (HICL) Levoketoconazole
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P1
Therapeutic class — intermediate (HIC2) Anteriorpituitary Hormones
HIC3 code P1G
Therapeutic class — specific (HIC3) Adrenal Steroid Inhibitors
AHFS code 68:04.00.00
AHFS class Adrenals
FDB label name RECORLEV 150 MG TABLET
FDB brand name Recorlev
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 082947
  • GCN: 51757
  • GPI-14 (Medi-Span): 30022040000320
  • HICL (First Databank): 047743
  • AHFS class code: 68:04.00.00
  • RxCUI (RxNorm): 2588848
Why two NDCs? The FDA registers this code as 72065-003-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 72065-0003-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Cortisol Synthesis Inhibitor class.

Pharmacologic class Cortisol Synthesis Inhibitor, Azole Antifungal
Drug family (ATC) Anticorticosteroids, Imidazole and triazole derivatives, Imidazole derivatives
How it works Cytochrome P450 2B6 Inhibitors, Cytochrome P450 3A4 Inhibitors, Cytochrome P450 17A1 Inhibitors, P-Glycoprotein Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name RECORLEV 150 MG TABLET Ingredient Levoketoconazole
📖 What it is MedlinePlus · NLM

Ketoconazole is used to treat fungal infections when other medications are not available or cannot be tolerated. Ketoconazole should not be used to treat fungal meningitis (infection of the membranes surrounding the brain and spinal cord caused by a fungus) or fungal nail infections. Ketoconazole is in a class of antifungals called imidazoles. It works by slowing the growth of fungi that cause infection.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Recorlev contains levoketoconazole, which is chemically related to an antifungal called ketoconazole — but Recorlev itself is NOT approved to treat fungal infections. It's specific...
  • What exactly is Recorlev used for — is it the same as a regular antifungal?
  • Your doctor will check your cortisol levels using 24-hour urine collections every few weeks, especially while your dose is being adjusted. If cortisol levels come down into the nor...
  • Nausea, headache, fatigue, and some stomach upset are common and usually manageable. But there are a few things that need a call to your doctor right away: yellowing of your skin o...
📖 Read our full Levoketoconazole guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $394.64 $19,731.82 / 50 tablets
Medicare drug plans payPart D · Q2 2026 $391.35 $19,567.29 / 50 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
72065-0003-01 You're viewing this Main listing 50 TABLET in 1 BOTTLE 2021-12-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Recorlev 150 mgthis 72065-0003-01 Xeris 50 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2021
First FDA approval
Dec 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2040
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Mar 2040. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 30, 2021 RLD RS ⏳ ~13.4 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 12377096 — method of use (U-4236)
US 11278547 — method of use (U-3282)
US 11478471 — method of use (U-3283)
US 10835530 — method of use (U-3283)
US 10517868 — method of use (U-3283)
US 10098877 — method of use (U-3283)
US 9918984 — method of use (U-3283)
US 11903940 — method of use (U-3821)
US 11020393 — method of use (U-3282)
Exclusivity NCE*
Exclusivity ODE-385
2021 2023 2025 2027 2029 2031 2033 2035 2037 2039
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (9)
PatentTypeUse codeExpires
US 12377096 ↗ Method of use U-4236 Mar 2, 2040
US 11278547 ↗ Method of use U-3282 Mar 2, 2040
US 11478471 ↗ Method of use U-3283 Jan 10, 2026
US 10835530 ↗ Method of use U-3283 Jan 10, 2026
US 10517868 ↗ Method of use U-3283 Jan 10, 2026
US 10098877 ↗ Method of use U-3283 Jan 10, 2026
US 9918984 ↗ Method of use U-3283 May 3, 2028
US 11903940 ↗ Method of use U-3821 Mar 2, 2040
US 11020393 ↗ Method of use U-3282 Mar 2, 2040
FDA exclusivity
CodeWhat it grantsExpires
NCE*New Chemical Entity (5-year)Dec 30, 2026
ODE-385Orphan Drug Exclusivity (7-year)Dec 30, 2028
Common questions
Is there a generic version of RECORLEV 150 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for RECORLEV 150 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Mar 2040 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerXeris Pharmaceuticals, Inc.
Application holderSTRONGBRIDGE DUBLIN LTD
FDA applicationNDA214133 (NDA)
Labeler code72065
First marketedDec 2021
Product typeHuman Prescription Drug
Portfolio6 products on file

More NDCs from Xeris Pharmaceuticals, Inc. labeler code 72065

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Medication Guide 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~2 min read ▾

WARNING: HEPATOTOXICITY AND QT PROLONGATION Hepatotoxicity • Cases of hepatotoxicity with a fatal outcome or requiring liver transplantation have been reported with use of oral ketoconazole. Some patients had no obvious risk factors for liver disease. Serious hepatotoxicity has been reported in patients receiving RECORLEV [see Warnings and Precautions ( 5.1 )]. • RECORLEV is contraindicated in patients with cirrhosis, acute liver disease or poorly controlled chronic liver disease, recurrent symptomatic cholelithiasis, a prior history of drug induced liver injury due to ketoconazole or any azole antifungal therapy that required discontinuation of treatment, or extensive metastatic liver disease [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )]. • Evaluate liver enzymes prior to and during treatment.

Interrupt RECORLEV treatment immediately if signs of hepatotoxicity occur [see Dosage and Administration ( 2.1 , 2.3 , 2.4 ), Warnings and Precautions ( 5.1 )]. QT Prolongation • RECORLEV is associated with dose-related QT interval prolongation. QT interval prolongation may lead to life-threatening ventricular dysrhythmias such as torsades de pointes [see Warnings and Precautions ( 5.2 )]. • Coadministration of RECORLEV with other drugs that prolong the QT interval associated with ventricular arrhythmias, including torsades de pointes, and use in patients with a prolonged QTcF interval of greater than 470 msec at baseline, history of torsades de pointes, ventricular tachycardia, ventricular fibrillation, or long QT syndrome (including first-degree family history) are contraindicated [see Contraindications ( 4 ), Drug Interactions ( 7.1 , 7.2 )]. • Perform an ECG and correct hypokalemia and hypomagnesemia prior to and during treatment.

Temporarily discontinue RECORLEV if QTcF interval exceeds 500 msec [Dosage and Administration ( 2.1 , 2.3 , 2.4 )]. WARNING: HEPATOTOXICITY AND QT PROLONGATION See full prescribing information for complete boxed warning. Cases of hepatotoxicity with fatal outcome or requiring liver transplantation have been reported with oral ketoconazole.

Some patients had no obvious risk factors for liver disease. RECORLEV is associated with serious hepatotoxicity. Evaluate liver enzymes prior to and during treatment ( 5.1 ) RECORLEV is associated with dose-related QT interval prolongation.

QT interval prolongation may result in life-threatening ventricular dysrhythmias such as torsades de pointes. Perform ECG prior to and during treatment ( 5.2 )

🎯 Indications and Usage 110 words ▾

1 INDICATIONS AND USAGE RECORLEV is indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. Limitations of Use RECORLEV is not approved for the treatment of fungal infections. The safety and effectiveness of RECORLEV for the treatment of fungal infections have not been established.

RECORLEV is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative ( 1 ) Limitations of Use RECORLEV is not approved for the treatment of fungal infections ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Obtain baseline liver and electrocardiogram tests and correct hypokalemia and hypomagnesemia before starting RECORLEV ( 2.1 ) Initiate dosage at 150 mg orally twice daily, with or without food. Titrate dosage by 150 mg daily, no more frequently than every 2-3 weeks ( 2.2 ) Maximum recommended dosage is 1200 mg daily, administered as 600 mg twice daily ( 2.2 ) For additional recommendations on titration and monitoring for efficacy, see Full Prescribing Information ( 2.2 ) For recommendations on safety monitoring and dosage modifications for hepatotoxicity, QT prolongation and hypocortisolism, see Full Prescribing Information ( 2.3 , 2.4 )

2.1Laboratory Testing Prior to RECORLEV Initiation Obtain baseline liver tests [alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin]. Carefully consider the risks and potential benefits of initiating RECORLEV in patients with AST or ALT above normal but less than or equal to 3 times the upper limit of normal [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )]. Obtain baseline electrocardiogram (ECG) [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 )].

Correct hypokalemia and hypomagnesemia prior to starting RECORLEV [see Warnings and Precautions ( 5.2 )].

2.2Recommended Dosage, Titration, and Monitoring for Efficacy Initiate dosage at 150 mg orally twice daily, with or without food [see Clinical Pharmacology ( 12.3 )]. Titrate the dosage by 150 mg daily, no more frequently than every 2-3 weeks based on 24-hour urine free cortisol levels and patient tolerability [see Dosage and Administration ( 2.4 )] . Monitor cortisol levels from at least two 24-hour urine free cortisol collections every 2-3 weeks until an adequate clinical response is achieved.

The maximum recommended dosage is 1200 mg per day, administered as 600 mg twice daily. The dosage may be reduced to 150 mg once daily if needed for reasons of tolerability [see Dosage and Administration ( 2.3 , 2.4 )]. Once the maintenance dosage is achieved, monitor cortisol levels from at least two 24-hour urine free cortisol collections at least every 1-2 months or as indicated.

If 24-hour urine free cortisol levels remain above the upper normal limit after treatment with the maximum recommended dosage of 1200 mg per day, or the patient cannot tolerate treatment with RECORLEV, consider discontinuing RECORLEV and switching patient to another therapy.

2.3Monitoring for Safety Perform the following monitoring during RECORLEV treatment. Refer to Dosage Interruptions and Modifications below for recommendations pertaining to management of liver, cortisol, or ECG abnormalities [see Dosage and Administration ( 2.4 )]. Hepatotoxicity Serious hepatotoxicity has been reported in patients receiving RECORLEV, and therefore frequent monitoring of liver tests is recommended.

Monitor liver enzymes and bilirubin weekly for at least 6 weeks after starting RECORLEV, every 2 weeks for the next 6 weeks, monthly for the next 3 months, and then as clinically indicated. After any dose interruption or dose increase, monitor on a weekly basis until a stable dosage is achieved [see Warnings and Precautions ( 5.1 )]. QT Prolongation Conduct an ECG before each dose increase.

After a stable dosage is established, monitor routinely for an effect on the QT interval. Monitor blood potassium and magnesium levels periodically during treatment [see Warnings and Precautions ( 5.2 )]. Hypocortisolism Monitor 24-hour urine free cortisol, morning serum or plasma cortisol, and patient’s signs and symptoms for hypocortisolism periodically during RECORLEV treatment [see Warnings and Precautions ( 5.3 )].

2.4Dosage Interruptions and Modifications Hepatotoxicity Refer to Table 1 for management of hepatotoxicity [see Warnings and Precautions ( 5.1 ) ] . Table 1: Dosage Modification and Management for Hepatotoxicity ALT or AST Total Bilirubin Recommendation ≥ 5 x ULN Any value Permanently discontinue RECORLEV.… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 34 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 150 mg, round, pink, film-coated, and imprinted in black ink with “LEV” above “150” on one side; the other side is plain. Tablets: 150 mg ( 3 )

⛔ Contraindications ~1 min read ▾

4 CONTRAINDICATIONS RECORLEV is contraindicated in patients: With cirrhosis, acute liver disease or poorly controlled chronic liver disease, baseline AST or ALT greater than 3 times the upper limit of normal, recurrent symptomatic cholelithiasis, a prior history of drug induced liver injury due to ketoconazole or any azole antifungal therapy that required discontinuation of treatment, or extensive metastatic liver disease [see Warnings and Precautions ( 5.1 )] . Taking drugs that cause QT prolongation associated with ventricular arrhythmias, including torsades de pointes [see Warnings and Precautions ( 5.2 )] .

With a prolonged QTcF interval of greater than 470 msec at baseline, history of torsades de pointes, ventricular tachycardia, ventricular fibrillation, or long QT syndrome (including first-degree family history) [see Warnings and Precautions ( 5.2 )] . With known hypersensitivity to levoketoconazole, ketoconazole or any excipient in RECORLEV [see Warnings and Precautions ( 5.4 ), Adverse Reactions ( 6.2 )] . Taking certain drugs that are sensitive substrates of CYP3A4 or CYP3A4 and P-gP [see Drug Interactions ( 7.1 )] .

Cirrhosis, acute liver disease or poorly controlled chronic liver disease, baseline AST or ALT > 3 times the upper limit of normal, recurrent symptomatic cholelithiasis, a prior history of drug induced liver injury due to ketoconazole or any azole antifungal therapy that required discontinuation of treatment, or extensive metastatic liver disease ( 4 ) Taking drugs that cause QT prolongation associated with ventricular arrhythmias, including torsades de pointes ( 4 ) Prolonged QTcF interval > 470 msec at baseline, history of torsades de pointes, ventricular tachycardia, ventricular fibrillation, or prolonged QT syndrome ( 4 ) Hypersensitivity to levoketoconazole, ketoconazole or any excipient in RECORLEV ( 4 ) Taking certain drugs that are sensitive substrates of CYP3A4 or CYP3A4 and P-gp ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hypocortisolism : Hypocortisolism has been reported with RECORLEV. Monitor patients for hypocortisolism. Dosage reduction or interruption may be necessary ( 5.3 ) Hypersensitivity Reactions: Hypersensitivity to RECORLEV has been reported.

Anaphylaxis has been reported with oral ketoconazole ( 5.4 ) Risks Related to Decreased Testosterone : RECORLEV may lower serum testosterone in men and women. Inform patients to report associated symptoms ( 5.5 )

5.1Hepatotoxicity Cases of hepatotoxicity with a fatal outcome or requiring liver transplantation have been reported with the use of oral ketoconazole, the racemic mixture from which levoketoconazole is derived. Some patients had no obvious risk factors for liver disease. Serious hepatotoxicity has been reported in patients receiving RECORLEV, irrespective of the dosages used or the treatment duration.

Drug-induced liver injury (peak ALT or AST greater than 3 times upper limit of normal) occurred in 13% of patients using RECORLEV. RECORLEV is contraindicated in patients with cirrhosis, acute liver disease or poorly controlled chronic liver disease, baseline AST or ALT greater than 3 times the upper limit of normal, recurrent symptomatic cholelithiasis, a prior history of drug induced liver injury due to ketoconazole or any azole antifungal therapy that required discontinuation of treatment, or extensive metastatic liver disease [see Contraindications ( 4 )] .

Avoid concomitant use of RECORLEV with hepatotoxic drugs. Advise patient to avoid excessive alcohol consumption while on treatment with RECORLEV [see Drug Interactions ( 7.3 )] . Prompt recognition of liver injury is essential.

At baseline, obtain liver tests [see Dosage and Administration ( 2.1 )] . During RECORLEV treatment, regularly monitor liver enzymes, with more frequent monitoring during dosage titration [see Dosage and Administration ( 2.3 )] . Permanently discontinue RECORLEV treatment immediately if AST or ALT exceeds or is equal to 5 times the upper limit of normal, or AST or ALT exceeds or is equal to 3 times the upper limit of normal and total bilirubin concentration increases to more than 2 times the upper limit of normal.

Repeat liver tests within approximately 3 days following the initial abnormal liver test, until the levels are stable. Monitor at regular intervals thereafter, no less than every 7 to 10 days, until resolution of the abnormality (or return to baseline levels) or until an alternative cause has been identified [see Dosage and Administration ( 2.4 )]. For AST or ALT elevations less than 3 times the upper limit of normal, or AST or ALT elevations equal to or greater than 3 to less than 5 times the upper limit of normal and total bilirubin concentration less than 2 times the upper limit of normal, monitor liver tests and manage hepatotoxicity with RECORLEV dosage interruption or modifications [see Dosage and Administration ( 2.4 )] .

If a liver abnormality significantly above the patient’s baseline recurs after restarting RECORLEV, permanently discontinue RECORLEV.

5.2QT Prolongation RECORLEV is associated with dose-related QT interval prolongation. QT interval prolongation may lead to life-threatening ventricular dysrhythmias such as torsades de pointes. During Studies 1 and 2, which excluded patients with baseline QTcF interval greater than 470 msec, 4 (2.4%) patients experienced QTcF>500 msec, and 23 (14.7%) patients experienced change-from-baseline QTcF >60 msec.

Resolution typically occurred following a dosage interruption and in some cases correction of electrolyte abnormalities. RECORLEV may also elevate plasma concentrations of certain drugs known to prolong QT intervals. Prolongation of the QT interval from certain drugs can result in life-threatening ventricular dysrhythmias such as torsades de pointes [see Drug Interactions ( 7.1 , 7.2 )] .

RECORLEV is contraindicated in patients taking other drugs known to cause QT interval prolongation associated with ventric… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hepatotoxicity [see Warnings and Precautions ( 5.1 )] QT Prolongation [see Warnings and Precautions ( 5.2 )] Hypocortisolism [see Warnings and Precautions ( 5.3 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] Risks related to Decreased Testosterone [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (incidence > 20%) are nausea/vomiting, hypokalemia, hemorrhage/contusion, systemic hypertension, headache, hepatic injury, abnormal uterine bleeding, erythema, fatigue, abdominal pain/dyspepsia, arthritis, upper respiratory infection, myalgia, arrhythmia, back pain, insomnia/sleep disturbances, and peripheral edema.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Xeris Pharmaceuticals, Inc. at 1-877-937-4737 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of RECORLEV was evaluated in a multicenter, randomized-withdrawal study (Study 1) and in a multicenter, single-arm, open-label study (Study 2). During the two studies, 166 patients were exposed to RECORLEV, of which 104 patients were exposed for more than 6 months and 51 patients were exposed for at least 1 year.

In both studies, most patients took RECORLEV twice daily in total daily dosages ranging from 300 mg to 1200 mg [see Clinical Studies ( 14 )] . Adverse reactions, excluding hepatic injury, reported in ≥10% of patients treated with RECORLEV in Study 1 are presented in Table 2 listed in order of overall decreasing frequency of events. Table 2: Adverse Reactions, Excluding Hepatic Injury, Occurring in ≥10% of Cushing’s Syndrome Patients Treated with RECORLEV in Study 1 N = total number of patients, n = number of patients experiencing the event, (%) = proportion of patients experiencing the event. a Hemorrhage/contusion includes blood urine present, epistaxis, eye hemorrhage, gingival bleeding, hematoma, hematuria, hemorrhoidal hemorrhage, melena, and scleral hemorrhage. b Arrhythmia includes electrocardiogram QT prolonged, electrocardiogram T wave abnormal, palpitations, sinus tachycardia, tachycardia paroxysmal, and ventricular extrasystoles. c Abdominal pain/dyspepsia includes abdominal pain, abdominal distension, dyspepsia, gastric disorder, and related terms Adverse Reaction Types N= 84 n (%) Nausea/Vomiting 25 (30%) Hypokalemia 24 (29%) Systemic hypertension 20 (24%) Hemorrhage/Contusion a 19 (23%) Headache 18 (21%) Abnormal uterine bleeding 17 (20%) Arrhythmia b 16 (19%) Fatigue 15 (18%) Upper respiratory infection 15 (18%) Abdominal pain/Dyspepsia c 13 (15%) Dizziness 13 (15%) Diarrhea 13 (15%) Decreased appetite 11 (13%) Dry mouth 9 (11%) Dry skin 9 (11%) Adrenal insufficiency 8 (10%) Other notable adverse reactions which occurred with a frequency less than 10% during Study 1 were: alopecia (6%), gastrointestinal infection (6%), urinary tract infection (6%), hypogonadism (2%), and hypersensitivity (1%).

Adverse reactions, excluding hepatic injury, reported in ≥10% of patients treated with RECORLEV in Study 2 are presented in Table 3 listed in order of overall decreasing frequency of events. Table 3: Adverse Reactions, Excluding Hepatic Injury, Occurring in ≥10% of Cushing’s Syndrome Patients Treated with RECORLEV in Study 2 N = total number of patients, n = number of patients experiencing the event, (%) = proportion of patients experiencing the event. a Erythema includes flushing. b Hemorrhage/Contusion includes blood urine present, conjunctival hemorrhage, ecchymosis, epistaxis, hematoma, hyphemia, and red blood cells urine. c Abdominal pain/dyspepsia includes abdominal discomfort, abdominal distension, dys… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Consult approved product labeling for drugs that are substrates of CYP3A4, P-gp, OCT2, and MATE prior to initiating RECORLEV ( 7.1 ) Sensitive CYP3A4 or CYP3A4 and P-gp Substrates : Concomitant use of RECORLEV with these substrates is contraindicated or not recommended ( 7.1 ) Atorvastatin : Use lowest atorvastatin dose possible and monitor for adverse reactions for dosages exceeding 20 mg daily ( 7.1 ) Metformin : Monitor glycemia, kidney function, and vitamin B12 and adjust metformin dosage as needed ( 7.1 ) Strong CYP3A4 Inhibitors or Inducers : Avoid use of these drugs 2 weeks before and during RECORLEV treatment ( 7.2 ) Gastric Acid Modulators : See Full Prescribing Information for recommendations regarding concomitant use with RECORLEV ( 7.2 )

7.1Effect of RECORLEV on Other Drugs Levoketoconazole is a strong CYP3A4 inhibitor, as well as an inhibitor of the drug transporters P-gp, OCT2, and MATE1 in vivo. In vitro, levoketoconazole inhibits CYP2B6 and CYP2C8. Concomitant use of RECORLEV with drugs that are substrates of these CYP enzymes and transporters may increase the risk of adverse reactions of these drugs.

Consult the approved product labeling for drugs that are substrates of CYP3A4, P-gp, OCT2, and MATE1 prior to initiating therapy with RECORLEV. Table 6 presents drugs affected by RECORLEV that are contraindicated or not recommended for use during RECORLEV use. It also includes the clinical impact and management recommendations for concomitant use of RECORLEV with atorvastatin and metformin.

Table 6: Effect of RECORLEV on CYP3A4 and Transporter Substrates a The drugs listed are substrates for CYP3A4 and/or P-gp. Other metabolism and/or transporter pathways may also contribute to elimination of the substrate drug. Consult the approved product labeling for the substrate drug for more information. b Strong CYP3A4 inhibitor [see Drug Interactions ( 7.2 )] . c Based on clinical drug interaction study with levoketoconazole.

CYP3A4 or CYP3A4 and P-gp Substrates a That May Prolong QT Clinical Impact Increases risk of QT prolongation and torsades de pointes. Prevention or Management Concomitant use of RECORLEV with other drugs that cause QT prolongation associated with ventricular arrhythmias, including torsades de pointes, is contraindicated [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 )]. Examples Bosutinib, cisapride, clarithromycin b, cobimetinib, crizotinib, disopyramide, dofetilide, dronedarone, eliglustat (in patients that are poor or intermediate metabolizers of CYP2D6 and in patients taking strong or moderate CYP2D6 inhibitors), ivabradine, methadone, midostaurin, nicardipine, pimozide, quinidine, and ranolazine.

Sensitive CYP3A4 or CYP3A4 and P-gp Substrates a Clinical Impact Increases plasma concentrations of the substrate and may increase the risk of the substrate’s adverse reactions. Prevention or Management Concomitant use of RECORLEV with sensitive CYP3A4 or CYP3A4 and P-gp substrate drugs is contraindicated or not recommended [see Contraindications ( 4 )] . Refer to the prescribing information of the substrate drug.

Examples Alfentanil, avanafil, buspirone, conivaptan b , dabigatran etexilate, darifenacin, darunavir, digoxin, ebastine, everolimus, fexofenadine, ibrutinib, lomitapide, lovastatin, lurasidone, midazolam, naloxegol, nisoldipine, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir b , triazolam, and vardenafil. CYP3A4 Substrate Atorvastatin c Clinical Impact Increases plasma concentration of atorvastatin c and may increase the risk of atorvastatin-associated myopathy and rhabdomyolysis [see Clinical Pharmacology ( 12.3 )] .

Prevention or Management Concomitant use of RECORLEV with atorvastatin may require a dose reduction of atorvastatin. Use the lowest atorvastatin dose possible and monitor for adverse reactions when atorvastatin dosage exceeds 20 mg daily . OCT2 and MATE Substrate Metformin c Clinical Impact Increases plasma concentration of metformin… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation : Advise not to breastfeed during treatment and for one day after final dose ( 8.2 )

8.1Pregnancy Risk Summary Levoketoconazole is the 2S, 4R enantiomer of ketoconazole. The available published data from case series and case-control studies on the use of the racemic ketoconazole during pregnancy are insufficient to determine a drug-associated risk of major birth defects. There are no available data on ketoconazole use during pregnancy to inform the risk of miscarriage.

There are risks to the mother and fetus from untreated Cushing’s syndrome (see Clinical Considerations) . No animal reproduction studies have been performed with levoketoconazole. However, levoketoconazole constituted about 70% of the exposure in humans and animals after racemic ketoconazole administration.

In animal reproduction studies, embryotoxic effects were observed in pregnant mice, rats and rabbits, and fetal malformations were observed in rats, following oral dosing of racemic ketoconazole during the period of organogenesis at doses equal and less than the maximum recommended human dose (MRHD), respectively (see Data) . Advise pregnant women of the potential risk to a fetus and consider whether the benefits of treatment with RECORLEV outweigh the risks. The estimated background risk for major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15−20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Active Cushing’s syndrome during pregnancy has been associated with an increased risk of maternal and fetal morbidity and mortality (including gestational diabetes, gestational hypertension, pre-eclampsia, maternal death, miscarriage, intrauterine fetal demise, preterm birth and neonatal death).

Labor or Delivery Dystocia (difficult labor) was noted in mice and rats administered oral ketoconazole during the period of organogenesis at exposures below the MRHD of levoketoconazole (by body surface area (BSA)). The clinical relevance of these findings for human is unknown. Data Animal Data Racemic ketoconazole containing levoketoconazole was administered orally to rats, mice, and rabbits during the period of organogenesis.

Levoketoconazole constituted about 70% of the exposure in animals after racemic ketoconazole administration. Mice were administered 10, 20, and 40 mg/kg/day ketoconazole during the period of organogenesis (gestation days 6 to 18). Embryolethality (resorptions and still births) was observed at ≥ 20 mg/kg/day (below the MRHD of levoketoconazole based on BSA comparison).

There was no maternal toxicity in mice up to the highest dose of 40 mg/kg/day (below the MRHD of levoketoconazole by BSA), however, females failed to deliver naturally and Cesarean examination 3 days after the due date showed increased resorptions and dead fetuses. Rats were administered 10, 20, 40, and 80 mg/kg/day during the period of organogenesis (gestation days 6 to 18). Increased incidences of resorbed fetuses and still births were noted at ≥40 mg/kg/day (below the MRHD of levoketoconazole by BSA).

Fetal malformations (oligodactyly, syndactyly, absence of metacarpal and/or metatarsal bones, and cleft palate) were noted at ≥80 mg/kg/day of ketoconazole (at the MRHD of levoketoconazole by BSA). Dystocia and prolonged gestation were observed in rats at ≥10 mg/kg/day (below the MRHD of levoketoconazole by BSA). In rabbits, oral gavage doses of 0, 10 and 40 mg/kg/day ketoconazole were administered during the period of organogenesis (gestation days 6 through 18).

Increased incidences of resorbed fetuses and still births were observed at ≥10 mg/kg/day (below MRHD of levoketoconazole by BSA).

8.2Lactation Risk Summary Published data from one lact… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 27 words ▾

10 OVERDOSAGE In the event of acute accidental overdose, treatment consists of supportive and symptomatic measures. Within the first hour after ingestion, activated charcoal may be administered.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action In vitro, levoketoconazole inhibits key steps in the synthesis of cortisol and testosterone, principally those mediated by CYP11B1 (11β hydroxylase), CYP11A1 (the cholesterol side-chain cleavage enzyme, the first step in the conversion of cholesterol to pregnenolone), and CYP17A1 (17α-hydroxylase).

12.2Pharmacodynamics Cardiac Electrophysiology The largest mean increase in QTc was 24 msec (UCI: 31 msec) following administration of levoketoconazole 150 mg to 600 mg twice daily (the approved recommended dosage) in patients with endogenous Cushing’s syndrome. The increase in QTc was dose-related.

12.3Pharmacokinetics Absorption Peak plasma concentrations of levoketoconazole occur approximately 1.5 to 2 hours following oral administration of a single dose of RECORLEV under fasted conditions regardless of dose. In healthy volunteers, C max increases approximately proportionally with dose, while AUC increases greater than dose proportionally from 150 mg to 600 mg. Levoketoconazole accumulates in plasma during multiple dosing of RECORLEV.

Levoketoconazole is a substrate of the intestinal (and liver) efflux transporter, P-gp. Effect of Food In a healthy volunteer study (N = 24), subjects administered a single, 600 mg oral dose of RECORLEV tablets with a high-fat meal (total caloric content of 875 calories; 160 protein calories, 170 carbohydrate calories, and 545 fat calories) resulted in an increase of AUC by 30% and no change in C max . The median T max was delayed from 2 to 4 hours.

These changes are not considered to be clinically significant. Distribution Levoketoconazole has an apparent volume of distribution of 31 to 41 L, approximating total body water. Protein binding of levoketoconazole in human plasma is high (99.3%).

Elimination Metabolism No in vitro or in vivo studies of levoketoconazole metabolism have been performed. Racemic ketoconazole is metabolized extensively in the liver to several inactive metabolites (with respect to antifungal activity). CYP3A4 is the major enzyme involved in the metabolism of ketoconazole.

The major identified metabolic pathways are oxidation and degradation of the imidazole and piperazine rings. In addition, oxidative O-dealkylation and aromatic hydroxylation occurs. Excretion Levoketoconazole is eliminated from plasma with a half-life of 3 to 4.5 hours after a single dose and 4 to 6 hours after multiple doses.

A mass-balance study has not been performed with levoketoconazole. Approximately 13% of a racemic ketoconazole dose is excreted in the urine, of which 2 to 4% is unchanged drug. The major route of excretion is through the bile into the intestinal tract with about 57% being excreted in the feces.

Specific Populations Population pharmacokinetic modeling data from patients with Cushing’s syndrome suggest there is no impact of age or sex on the pharmacokinetics of levoketoconazole. The pharmacokinetics of levoketoconazole have not been formally studied in geriatric patients. Levoketoconazole has not been studied in patients younger than 18 years of age.

Differences in pharmacokinetics among race/ethnicity groups are unknown. Patients with Renal or Hepatic Impairment Levoketoconazole has not been studied in patients with renal or hepatic impairment. The overall pharmacokinetics of racemic ketoconazole was not significantly altered in patients with renal failure when compared with healthy volunteers. [see Contraindications ( 4 )] .

Given the extensive hepatic metabolism of ketoconazole, it is expected that clearance would be reduced in patients with impaired liver function. Drug Interaction Studies Levoketoconazole is a strong CYP3A4 inhibitor, as well as an inhibitor of the drug transporters P-gp, OCT2, and MATE1 in vivo. Concomitant administration of medications that are substrates of these enzymes or transporters may have their plasma concentrations affected by RECORLEV [see Drug Interactions ( 7.1 )] .

Clinical drug interaction studies… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 82 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied RECORLEV (levoketoconazole) tablets, 150 mg are round, biconvex tablets, with a pink-colored film coating, containing 150 mg of levoketoconazole, and imprinted with an identification code in black ink with the “LEV” printed above the “150” on one side. The other side is plain. Bottles of 50 with child-resistant closure: NDC 72065-003-01 Storage Store RECORLEV at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) (see USP controlled room temperature).

📋 Description 160 words ▾

11 DESCRIPTION RECORLEV (levoketoconazole) tablets contain levoketoconazole as the active ingredient. Levoketoconazole is the 2S,4R- enantiomer derived from racemic ketoconazole and is a cortisol synthesis inhibitor. The chemical name of levoketoconazole is 2S,4R cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl] methoxyl]phenyl] piperazine.

The molecular formula of levoketoconazole is C 26 H 28 Cl 2 N 4 O 4 with a molecular mass of 531.43 g/mol. Levoketoconazole is a white or almost white crystalline powder. It is very slightly soluble in water but soluble in aqueous solutions below pH 2.

RECORLEV tablets for oral administration contain 150 mg of levoketoconazole and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, modified corn starch, and silicified microcrystalline cellulose. The non-functional pink film-coating contains iron oxide red, macrogol/polyethylene glycol 3350, polyvinyl alcohol partially hydrolyzed, talc, and titanium dioxide. The tablets are printed with a black imprinting ink that contains ammonium hydroxide 28%, ferrosoferric oxide, isopropyl alcohol, propylene glycol, and shellac glaze 45% (20% esterified) in ethanol.

Structure

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE RECORLEV ® MEDICATION GUIDE RECORLEV® (re kor ' lev) (levoketoconazole) tablets, for oral use What is the most important information I should know about RECORLEV? RECORLEV can cause serious side effects, including: Liver damage (hepatotoxicity). Hepatotoxicity can happen in people who take RECORLEV.

Some people who are treated with ketoconazole, a medicine like the active ingredient in RECORLEV, had serious liver problems that required a liver transplant or led to death. Call your healthcare provider right away if you have any of the following signs or symptoms: pain on the upper right side of your stomach area (abdomen) associated with nausea unusual fatigue yellowing of your skin or the whites of your eyes (jaundice) unusual bruising or bleeding RECORLEV should not be used if you have any of the following conditions: cirrhosis active or poorly controlled liver disease frequent stones in your gallbladder (cholelithiasis) history of liver problems due to use of a drug Your healthcare provider will do liver tests before and during treatment with RECORLEV.

Heart rhythm problems (QT prolongation). RECORLEV can cause a heart problem called QT interval prolongation, or QT prolongation. QT prolongation can cause irregular heartbeats that can be life threatening.

Call your healthcare provider right away if you feel severe lightheadedness or if you faint during treatment with RECORLEV. Low blood electrolyte levels of potassium and magnesium can increase your chances of QT prolongation during treatment with RECORLEV. Your healthcare provider will check your heart with a test called an electrocardiogram (ECG) and do blood tests to check your blood electrolyte levels before and during treatment with RECORLEV.

RECORLEV should not be taken with certain other medicines that cause QT prolongation. Talk to your healthcare provider about the medicines you are taking before you start taking RECORLEV. Low cortisol levels (adrenal insufficiency).

Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones, such as cortisol. RECORLEV may cause adrenal function insufficiency by excessively lowering production of cortisol. Call your healthcare provider right away if you have one or more of the following symptoms, as these may be symptoms of reduced adrenal function: nausea or vomiting dizziness unusual fatigue low blood pressure (hypotension) unexplained stomach pain (abdomen) abnormal electrolyte levels loss of appetite low blood sugar (hypoglycemia) body aches Your healthcare provider will collect blood or urine samples to measure your cortisol.

What is RECORLEV? RECORLEV is a prescription medicine used to treat high cortisol (endogenous hypercortisolemia) levels in adult patients with Cushing’s syndrome (CS) who cannot have surgery or who have had surgery that did not cure their Cushing's syndrome. It is not known if RECORLEV is safe and effective for the treatment of fungal infections.

RECORLEV is not to be used for treatment of fungal infections. Do not take RECORLEV if you: have or have had liver problems. take certain other medicines that cause QT prolongation. have a history of certain heart problems which may include one the following conditions: torsades de pointes, ventricular tachycardia, ventricular fibrillation, or long QT syndrome. are allergic to levoketoconazole, ketoconazole, or any of the ingredients in RECORLEV. See the end of this Medication Guide for a complete list of ingredients in RECORLEV. take certain medicines that may affect how your liver works (for example, CYP3A4 inhibitors).

If you are not sure if you take these medicines, please ask your healthcare provider. Before taking RECORLEV, tell your healthcare provider about all of your medical conditions, including if you: have or have had liver problems. have any heart problems, including a condition called long QT syndrome. have a history of low blood levels of potassium or magnesium. are pregnant or plan to becom… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The effectiveness of RECORLEV in patients with Cushing's syndrome was evaluated in two studies, Study 1 and Study 2. Study 1 Study 1 consisted of an open-label dose titration and maintenance phase of up to 19 weeks duration, followed by an 8-week double-blind, placebo-controlled, randomized withdrawal phase ( NCT03277690 ). Study 1 enrolled 84 Cushing’s syndrome patients with persistent or recurrent disease despite surgery, previously medically treated patients, and previously untreated patients.

The etiology of Cushing's syndrome was Cushing's disease for 70 (83%) patients, adrenal Cushing’s syndrome in 8 (10%) patients, ectopic ACTH secretion for 2 (2%) patients, and unknown for 4 (5%) patients. Patients with pituitary or adrenal carcinoma were excluded. Twelve (14%) patients who had previously received RECORLEV in Study 2 were also enrolled in Study 1.

The mean age at baseline was 45 years; 76% of patients were female. Overall, the mean time since diagnosis was 63 months before treatment with the first dose in this study. Persistence or recurrence of Cushing’s syndrome was evidenced by the mean of three 24-hour UFC levels greater than or equal to 1.5 × upper limit of normal (normal range: 11 to 138 nmol/day or 4 to 50 µg/day).

For the 79 patients who underwent dose titration, the mean mUFC (SD) at study baseline was 785 nmol/day (932), which corresponds to approximately 6 × ULN. The median mUFC at baseline was 479 nmol/day, which corresponds to approximately 3.5 × ULN. Seventy-two (72) patients were naïve to treatment with RECORLEV, seven (7) patients were treated with RECORLEV in Study 2 but were not on therapeutic dose (dose at which mUFC level was ≤ ULN, or maximum allowed dose [600 mg twice daily] had been reached, or a clinically meaningful partial response based on clinical judgement, and the maximum tolerated dose had been reached) prior to the enrollment in Study 1.

Five (5) of 84 patients continued treatment with therapeutic dose of RECORLEV prior to the enrollment in Study 1; these patients were enrolled directly in the randomized withdrawal phase. Dose Titration and Maintenance Phase (14-19 weeks) Seventy-nine (79) patients entered the dose titration and maintenance phase. Patients naïve to treatment with RECORLEV were started on 150 mg of RECORLEV orally twice daily.

Patients who previously participated in Study 2 could start on a dose higher than 150 mg twice daily. The dose could be titrated in 150-mg increments at 2-week intervals to a maximum of 600 mg twice daily to achieve mUFC within the normal range. The dose was increased if mUFC was above ULN and was reduced based on individual tolerability.

Patients who achieved a stable therapeutic dose for at least 4 weeks and achieved a normal mUFC at the end of the dose titration and maintenance phase were eligible for the randomized withdrawal phase. Randomized Withdrawal Phase (approximately 8 weeks) Forty-four (44) patients entered the randomized withdrawal phase: 39 patients from dose titration and maintenance phase and 5 patients directly from Study 2. Patients were randomized in a 1:1 ratio to either continue RECORLEV or receive matched placebo for approximately 2 months or until early rescue was necessary (i.e., for mUFC >1.5 × ULN).

Efficacy Assessment and Results The key secondary efficacy endpoint was the proportion of patients with mUFC normalization, defined as a patient with mUFC at or below the ULN at the end of randomized withdrawal phase without meeting a requirement for early rescue during the randomized withdrawal phase. Out of the 79 patients who entered the dose titration and maintenance phase, 37 (47%) patients who met the requirement to be on a stable therapeutic dose for at least 4 weeks and established normal mUFC at the end of the dose titration and maintenance phase, and 2 patients who did not meet the requirement due to abnormal mUFC, continued to the randomized-withdrawal phase.

Out of 5 patients from Study 2 who wer… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Levoketoconazole has not been evaluated for carcinogenic effects. Ketoconazole was not carcinogenic in an 18-month, oral study in Swiss albino mice or a 24-month oral carcinogenicity study in Wistar rats at dose levels of 5, 20 and 80 mg/kg/day of ketoconazole. The high dose in these studies was less than the MRHD of levoketoconazole in the mouse and equal to the MRHD of levoketoconazole in rats based on a BSA comparison.

Mutagenesis Mutagenic potential of levoketoconazole has not been evaluated. Ketoconazole did not show any signs of mutagenic potential when evaluated using the dominant lethal mutation test or the Ames Salmonella microsomal activator assay. Impairment of Fertility In animal fertility studies, oral ketoconazole impaired both male and female fertility in rats in a dose and duration dependent manner.

In female rats, oral doses up to 40 mg/kg of ketoconazole (lower than the MRHD for levoketoconazole by BSA) had no effect on fertility. Doses of ≥75 mg/kg of ketoconazole (at the MRHD for levoketoconazole by BSA) decreased the pregnancy rate and number of implantation sites, and in males decreased sperm content (motility, count, morphology), which correlated with lower plasma testosterone levels and testicular histological changes. When administered for longer durations (up to 3 months), decreased fertility in male rats was observed at doses as low as 24 mg/kg/day of ketoconazole (lower than the MRHD for levoketoconazole by BSA).

In male beagle dogs, an oral dose of 25 mg/kg/day ketoconazole for up to 4 weeks (at the MRHD for levoketoconazole by BSA) resulted in decreased sperm motility, decreased sperm count, increased abnormal sperm and atrophy of the testes. These effects were reversed after withdrawal of treatment.

📄 Package Label / Principal Display Panel 28 words ▾

Principal Display Panel-Bottle Label (50 Tablets) NDC 72065-003-01 50 Tablets Rx only Recorlev® (levoketoconazole) Tablets 150 mg Dispense the Medication Guide provided separately to each patient. Bottle Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
316
Units reimbursed last 4 qtrs
22.3K
Gross reimbursed last 4 qtrs
$8.8M
Avg / prescription
$27,836.86
Avg / unit
$394.64
Latest quarter Q4 2025
96Rx
Fee-for-service vs managed care ⓘ
79% FFS 21% MCO
Fee-for-service · 250 Rx Managed care · 66 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 3,030 units · 30.2 per 100k residents MI New York: 4,050 units · 20.7 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 10,680 units · 27.4 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 1,590 units · 25.7 per 100k residents MD Connecticut: 2,940 units · 81.3 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
20.781.3
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Connecticut 81.3 /100k
2 Michigan 30.2 /100k
3 California 27.4 /100k
4 Maryland 25.7 /100k
5 New York 20.7 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Recorlev — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Recorlev. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$26.92M
Claims incl. refills
936
Beneficiaries
430
Spend / beneficiary
$62,597.59
Spend / claim
$28,757.44
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Levoketoconazole — the ingredient across all brands.

Top reported reactions

Fatigue237
Nausea206
Headache166
Dizziness101
Vomiting97
Diarrhoea83
Pain83

Age at onset

Adult27
Elderly36

Reporter sex

694 reports
Male · 21%
Female · 79%

Serious outcomes

Hospitalization172
Death12
Disabling4
Life-threatening2
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 320 49
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Xeris Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Xeris Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 72065-0001-01 · Xeris 72065-0120-11 · Xeris →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.